Back to resultsFeasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling (CASA-I)
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
TAP-II
Lancet capillary sampling
Venipuncture
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Capillary sampling, CEA, Colorectal cancer, Home-based
Eligibility Criteria
Inclusion Criteria: Arm A: subjects with known elevated serum CEA Age ≥ 21 years Histologically confirmed (metastatic) colorectal adenocarcinoma Serum CEA ≥ 10 μg/L within the last 2 months determined using venipuncture blood sampling Arm B: subjects currently undergoing colorectal cancer related follow-up Age ≥ 21 years Histologically confirmed (metastatic) colorectal adenocarcinoma Currently undergoing in-hospital follow-up with at least two more scheduled serum CEA assessments 3-6 months apart Arm C: volunteers Age ≥ 21 years No known history of colorectal adenocarcinoma No known history of elevated serum CEA ≥ 5 μg/L Exclusion Criteria: Illiteracy and/or insufficient proficiency of the Dutch language Severe or complete loss of sensory and or motor function of one or both arms and or hands Known medical history of superficial or deep skin infection after venipuncture or intravenous line that required antibiotic treatment and or hospital admittance Known medical history of immunodeficiency or current use of medical immunosuppressants Known medical history of blood-borne diseases such as but not limited to the human immunodeficiency virus, hepatitis and viral hemorrhagic fever
Sites / Locations
- Erasmus MCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Subjects with known elevated serum CEA
Subjects currently undergoing colorectal cancer related follow-up
Volunteers
Arm Description
Before the start of sample collection questionnaire A on paper will be filled in by all study subjects. The order of sample collection will be: automated capillary sampling, lancet capillary sampling and venipuncture. Herein automated and lancet capillary sampling will be performed by the study subjects themselves whereas the venipuncture will be performed by the study personnel. After all sampling has been completed, the subject is asked to complete questionnaire B which will evaluate pain, burden, ease of use and preference. For subjects in arm A and C this entails the end of the study
The subjects of arm B are requested to perform automated capillary and lancet capillary sampling at home following their next two outpatient visits. During these outpatient visits, a reference value blood CEA measurement will be obtained using venipuncture by the personnel of the clinical laboratory of Erasmus MC. The required materials will be sent to the home address of the patient. Sampling will be performed at home and by the subjects themselves. Subjects will have access to the tutorial videos for automated and lancet capillary sampling.
Before the start of sample collection questionnaire A on paper will be filled in by all study subjects. The order of sample collection will be: automated capillary sampling, lancet capillary sampling and venipuncture. Herein automated and lancet capillary sampling will be performed by the study subjects themselves whereas the venipuncture will be performed by the study personnel. After all sampling has been completed, the subject is asked to complete questionnaire B which will evaluate pain, burden, ease of use and preference. For subjects in arm A and C this entails the end of the study
Outcomes
Primary Outcome Measures
Feasibility of CEA assessments at home using (automated) capillary sampling
Home based (automated) capillary sampling will be considered feasible if a success rate of 85% or greater has been reached. Herein a successful (automated) capillary sampling at home is defined as a sampling of blood by the patient that reached the clinical laboratory of the hospital via post and in which a CEA level could be determined reliably. Both capillary sampling methods will be analysed and compared to venepuncture separately.
Secondary Outcome Measures
Reliability of the CEA measurements
Reliability will be assessed by a Bland-Altman analysis to determine mean bias and the 95% limits of agreement of measurements from (automated) capillary samples compared to venipuncture samples. These will be compared to predefined clinically relevant cut-off values for the mean bias and the limits of agreement. A mean bias of greater or equal to +/- 5% and or 95% limits of agreement equal to or greater than +/- 10% will be considered clinically relevant and thereby unreliable. These cut-off values are defined based on previously found 95% limits of agreement of the automated capillary sampling device and the precision of the Cobas 8000 analyzer which will be used to perform the CEA analyses.
Satisfaction of blood sampling
All study subjects will be asked to complete the questionnaire to evaluate pain, burden, ease of use and preference. Herein they are asked to provide their perceived level of pain separately for automated capillary sampling, lancet capillary sampling and venipuncture. A visual analogue scale ranging from 0 to 10 will be used to measure perceived level of pain. Pain measurements will be compared across all three sampling methods in the entire cohort of 100 subjects using repeated measures ANOVA. An α < 0.05 will be considered statistically significant.
Clinical laboratory sample processing time:
the sample processing time from entering the clinical laboratory until a successful measurement is obtained will be compared across all sampling methods using analysis of variance (ANOVA). An α < 0.05 will be considered statistically significant.
Full Information
NCT ID
NCT05646030
First Posted
December 2, 2022
Last Updated
September 6, 2023
Sponsor
Erasmus Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05646030
Brief Title
Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling
Acronym
CASA-I
Official Title
Feasibility, Reliability, and Satisfaction of Carcinoembryonic Antigen Measurements Using Home Based (Automated) CApillary Blood SAmpling; the Prospective CASA-I Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 25, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this study is to determine the feasibility of CEA assessments at home using (automated) capillary sampling in patients in the follow-up after treatment for colorectal cancer.
The main questions it aims to answer are:
To determine the success rate of capillary sampling at home by the patient
To assess reliability and satisfaction of (automated) capillary CEA measurements Participants will be asked to perform automated capillary sampling and lancet capillary sampling at home twice after regular check-up visits in the hospital, with an interval of 3-6 months in between. During this hospital visit, a CEA measurement in blood sampled by venipuncture will be performed to act as a reference for the CEA measurements in (automated) capillary blood to be sampled at home.
Reliability of CEA measurements will be assessed for automated capillary and lancet capillary sampling compared to venipuncture.
Satisfaction in terms of patient reported outcomes (pain, burden, ease of use, and preference) will be evaluated.
Detailed Description
The follow-up of patients after colorectal cancer surgery mainly consists of blood CEA assessments. These blood assessments could be done at home and could be beneficial in terms of patients' well-being and societal cost-effectiveness. Capillary blood sampling can be an alternative to venipuncture in home based or decentralized surveillance as it can be performed by the patient themselves. Before home based capillary sampling can be implemented, feasibility, reliability, and satisfaction for serum CEA measurements has to be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Capillary sampling, CEA, Colorectal cancer, Home-based
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective three-armed cohort study.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects with known elevated serum CEA
Arm Type
Other
Arm Description
Before the start of sample collection questionnaire A on paper will be filled in by all study subjects. The order of sample collection will be: automated capillary sampling, lancet capillary sampling and venipuncture. Herein automated and lancet capillary sampling will be performed by the study subjects themselves whereas the venipuncture will be performed by the study personnel. After all sampling has been completed, the subject is asked to complete questionnaire B which will evaluate pain, burden, ease of use and preference.
For subjects in arm A and C this entails the end of the study
Arm Title
Subjects currently undergoing colorectal cancer related follow-up
Arm Type
Other
Arm Description
The subjects of arm B are requested to perform automated capillary and lancet capillary sampling at home following their next two outpatient visits. During these outpatient visits, a reference value blood CEA measurement will be obtained using venipuncture by the personnel of the clinical laboratory of Erasmus MC. The required materials will be sent to the home address of the patient. Sampling will be performed at home and by the subjects themselves. Subjects will have access to the tutorial videos for automated and lancet capillary sampling.
Arm Title
Volunteers
Arm Type
Other
Arm Description
Before the start of sample collection questionnaire A on paper will be filled in by all study subjects. The order of sample collection will be: automated capillary sampling, lancet capillary sampling and venipuncture. Herein automated and lancet capillary sampling will be performed by the study subjects themselves whereas the venipuncture will be performed by the study personnel. After all sampling has been completed, the subject is asked to complete questionnaire B which will evaluate pain, burden, ease of use and preference.
For subjects in arm A and C this entails the end of the study
Intervention Type
Diagnostic Test
Intervention Name(s)
TAP-II
Intervention Description
The TAP-II device will be compared to lancet capillary sampling and the venipuncture
Intervention Type
Diagnostic Test
Intervention Name(s)
Lancet capillary sampling
Intervention Description
The lancet capillary sampling will be compared to TAP device and the venipuncture
Intervention Type
Diagnostic Test
Intervention Name(s)
Venipuncture
Intervention Description
The venipuncture will be compared to TAP device and the lancet capillary sampling
Primary Outcome Measure Information:
Title
Feasibility of CEA assessments at home using (automated) capillary sampling
Description
Home based (automated) capillary sampling will be considered feasible if a success rate of 85% or greater has been reached. Herein a successful (automated) capillary sampling at home is defined as a sampling of blood by the patient that reached the clinical laboratory of the hospital via post and in which a CEA level could be determined reliably. Both capillary sampling methods will be analysed and compared to venepuncture separately.
Time Frame
Year 1 (6 months after the inclusion of the first patient)
Secondary Outcome Measure Information:
Title
Reliability of the CEA measurements
Description
Reliability will be assessed by a Bland-Altman analysis to determine mean bias and the 95% limits of agreement of measurements from (automated) capillary samples compared to venipuncture samples. These will be compared to predefined clinically relevant cut-off values for the mean bias and the limits of agreement. A mean bias of greater or equal to +/- 5% and or 95% limits of agreement equal to or greater than +/- 10% will be considered clinically relevant and thereby unreliable. These cut-off values are defined based on previously found 95% limits of agreement of the automated capillary sampling device and the precision of the Cobas 8000 analyzer which will be used to perform the CEA analyses.
Time Frame
Year 1 (6 months after the inclusion of the first patient)
Title
Satisfaction of blood sampling
Description
All study subjects will be asked to complete the questionnaire to evaluate pain, burden, ease of use and preference. Herein they are asked to provide their perceived level of pain separately for automated capillary sampling, lancet capillary sampling and venipuncture. A visual analogue scale ranging from 0 to 10 will be used to measure perceived level of pain. Pain measurements will be compared across all three sampling methods in the entire cohort of 100 subjects using repeated measures ANOVA. An α < 0.05 will be considered statistically significant.
Time Frame
Year 1 (6 months after the inclusion of the first patient)
Title
Clinical laboratory sample processing time:
Description
the sample processing time from entering the clinical laboratory until a successful measurement is obtained will be compared across all sampling methods using analysis of variance (ANOVA). An α < 0.05 will be considered statistically significant.
Time Frame
Year 1 (6 months after the inclusion of the first patient)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Arm A: subjects with known elevated serum CEA
Age ≥ 21 years
Histologically confirmed (metastatic) colorectal adenocarcinoma
Serum CEA ≥ 10 μg/L within the last 2 months determined using venipuncture blood sampling
Arm B: subjects currently undergoing colorectal cancer related follow-up
Age ≥ 21 years
Histologically confirmed (metastatic) colorectal adenocarcinoma
Currently undergoing in-hospital follow-up with at least two more scheduled serum CEA assessments 3-6 months apart
Arm C: volunteers
Age ≥ 21 years
No known history of colorectal adenocarcinoma
No known history of elevated serum CEA ≥ 5 μg/L
Exclusion Criteria:
Illiteracy and/or insufficient proficiency of the Dutch language
Severe or complete loss of sensory and or motor function of one or both arms and or hands
Known medical history of superficial or deep skin infection after venipuncture or intravenous line that required antibiotic treatment and or hospital admittance
Known medical history of immunodeficiency or current use of medical immunosuppressants
Known medical history of blood-borne diseases such as but not limited to the human immunodeficiency virus, hepatitis and viral hemorrhagic fever
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly R Voigt, MD
Phone
+31107042125
Email
k.voigt@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dirk J. Grünhagen, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
State/Province
Zuid Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly R Voigt, MD
Phone
+31629089053
Email
k.voigt@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Lissa Wullaert, MD
Phone
+316107042125
Email
l.wullaert@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Dirk J. Grünhagen, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility, Reliability, and Satisfaction of CEA Using Home Based (Automated) Capillary Blood Sampling
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